MS relapse

My multiple sclerosis (MS) brings fatigue, pain, and instability into my life, but surprisingly, it also makes me more aware of my life and surroundings. For me, that means being more aware in the present moment and focusing on the good in my life right now. Living in…

After 10-odd ― indeed, increasingly odd ― years, I presumed I’d become something of a gnarled hand at MS. If you read about something on practically a daily basis, you begin to think you’ve got pretty comprehensive knowledge of a subject. Sure, in the past, events happened that I…

I am an emotional, sensitive woman. I like to believe that I have a warm heart in a very cold world. Isn’t this what the world needs? Love, warmth, acceptance and transparency? Recently I find that my emotions change within a millisecond. So, instead of being sensitive, I…

Australia has become the first country to approve Genentech's Ocrevus for relapsing and primary progressive multiple sclerosis treatment since the therapy's initial approval by the U.S. Food and Drug Administration in March 2017. The Australian Therapeutic Goods Administration gave Ocrevus the green light on July 17, filling an unmet need for Australia's estimated 23,000 MS patients. “We are pleased that another regulatory body recognized for its rigorous review process has approved Ocrevus with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,” Dr. Sandra Horning, Roche’s chief medical officer and head of global product cevelopment, said in a press release. “Approval in Australia is significant because of the high prevalence of MS in the country, making it the leading cause of non-traumatic disability in young adults." The drug's developer, Genentech, and Genentech's parent company Roche have submitted applications to get Ocrevus approved in more than 50 countries in Europe, Latin America and the Middle East. Ocrevus trials showed that, among relapsing patients, relapse rates were nearly halved compared to those treated with Rebif. Many of these patients also reached a level of no disease activity — measures that Genentech has continued to explore after the drug's U.S. approval. In addition, data also showed that PPMS patients, who deteriorate more rapidly, benefit from Ocrevus treatment. “People with PPMS [primary progressive multiple sclerosis], who often experience faster and more severe disability, have not had any approved treatment until Ocrevus," Horning said. "We continue to work closely with regulatory authorities across the world to bring Ocrevus to people with multiple sclerosis as soon as possible." Ocrevus is an antibody that blocks the CD20 molecule on certain immune B-cells. Researchers believe these cells directly damage myelin — the protective coat that insulates nerve cells in the brain and spinal cord. Evidence also indicates that B-cells can directly damage neurons themselves. The drug continues to be evaluated in a range of clinical trials, including one that specifically focuses on how the drug’s B-cell depleting actions play out to harness MS disease processes.

I was watching my son’s baseball game in the early 1990s when suddenly, my left eye went blurry and blocked my vision. It was a startling incident that lasted about two hours, and then it was gone. That was my introduction into the unpredictable world of multiple sclerosis…

People with multiple sclerosis have high levels of pro-inflammatory TH17 immune cells in their intestines that correlate with change in the micro-organism mix in their gut and the levels of their disease activity, a study reports. Researchers said the findings suggest that diet, probiotics and therapies that regulate TH17 cells could help treat MS. Probiotics are supplements containing beneficial bacteria. The study, “High frequency of intestinal TH17 cells correlates with microbiota alterations and disease activity in multiple sclerosis,” was published in the journal Science. Research has shown that TH17 cells, also known as T helper 17 cells, play a role in the development of MS. In fact, they were the first harmful immune T-cells to infiltrate the central nervous system, according to studies in animals Where TH17 cells become activated has been unclear, however. Studies in mice suggested it was mainly in the small intestine. Research has also indicated that their activation increases the potential for a person to develop an autoimmune brain disease like multiple sclerosis. An autoimmune disease occurs when the immune system, which defends the body against disease, decides that a person's healthy cells are foreign, and attacks those cells. Researchers decided to see if the findings in mouse models of MS applied to people with the disease. They discovered a link between higher levels of TH17 cells in MS patients' intestines and autoimmune brain problems. They also found a correlation between higher levels of TH17 cells and changes in patients' gut microbiome. The team then identified which bacteria were changing in the gut. Patients with increased levels of TH17 cells and higher disease activity had a higher ratio of Firmicutes to Bacteroidetes bacteria and more Streptococcus strains in their gut, particularly Streptococcus mitis and Streptococcus oralis. Previous studies have shown that these species promote TH17 cell differentiation in humans. Cell differentiation involves a cell transforming from one cell type to another — usually a more specialized type. This dramatically changes a cell's size, shape, metabolic — or fuel-burning — activity, and responsiveness to signals. Some studies have suggested a link between T-cell differentiation and brain autoimmune diseases. “On the basis of our findings, we speculate that, under certain conditions, or because of still unknown virulence factors, these Streptococcus strains can colonize the small intestine and favor TH17 cell differentiation in the human gut mucosa [linings],” researchers wrote. In addition to more Streptococcus bacteria, the team detected lower levels of Prevotella bacteria in MS patients with disease activity than in healthy controls or patients with no disease activity. This decrease may also promote TH17 cell differentiation because “Prevotella is capable of producing the anti-inflammatory metabolite propionate that limits intestinal TH17 cell expansion in mice," the researchers wrote. Overall, the team concluded that “our data demonstrate that brain autoimmunity is associated with specific microbiota modifications and excessive TH17 cell expansion in the human intestine.” The findings suggest that regulating TH17 cell expansion, along with changes in diet aimed at regulating intestinal linings, could be ways to help treat MS.

The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…

Genentech shared new insights into the workings of Ocrevus (ocrelizumab) and its effectiveness in reducing disease activity and slowing progression in relapsing and primary progressive multiple sclerosis (MS) at the recent 3rd Congress of the European Academy of Neurology (EAN). The new findings, previously reported here, built on analyses of information gathered during the three Phase 3 clinical trials assessing Ocrevus' safety and efficacy, as well as through monitoring patients in extension studies. The studies showed that nearly 40 percent of Ocrevus-treated relapsing patients and nearly 30 percent of primary progressive patients achieved NEPAD during the Phase 3 trials. In contrast, only 21.5 percent of those treated with Rebif and 9.4 percent receiving placebo achieved NEPAD — figures that demonstrate Ocrevus’ impact on patients’ lives, as well as Ocrevus’ ability to slow the decline in walking ability and other types of disabilities are comparable between patients with relapsing and primary progressive disease — data that demonstrate that the treatment acts on disease mechanisms that drive disability in both disease forms. How these effects play out in the long-term is the subject of ongoing research, as Genentech continues to follow these patients in an extension study. In addition, Ocrevus' prescription label strongly advises against pregnancy while on the treatment. Despite precautions, some women became pregnant during the trials. One of the meeting presentations narrated outcomes of these pregnancies; one healthy baby born at term and two ongoing pregnancies in women exposed to the drug. But while Genentech monitors women who become pregnant while on Ocrevus, the number of reported pregnancies is too small to draw conclusions about the treatment’s safety in pregnancy, and researchers do not know if Ocrevus also depletes B-cells in the fetus or in the baby born to a treated woman.

New analyses of how Merck’s Mavenclad (cladribine tablets) act to treat relapsing multiple sclerosis (MS) give researchers an entirely new picture of immune processes leading to the disease. Data showed that the drug lowers both immune B-cells and, to a lesser degree, T-cells. But the numbers of both cell…

MS patients who start treatment at a younger age, and whose condition requires hospitalization, are more likely to stop treatment, a Canadian study reports. The research, published in the journal Dovepress, dealt with the main reasons Canadian patients quit first-line injected disease-modifying therapies, or DMTs. It was titled “Persistence to disease-modifying therapies for multiple sclerosis in a Canadian cohort.” DMTs can reduce MS activity, but patients must stick with them in order for them to be effective. “There is currently a paucity of clinical trial data on what happens to individuals when they discontinue DMT," the researchers wrote. "However, recent preliminary evidence from observational studies suggest increased relapses and disability in those who discontinue DMT." Researchers sought to identify MS patients at higher risk of discontinuing treatment. They looked at Manitoba Province's medical database to identify the types of drugs MS patients were taking, and for how long. The analysis covered 721 patients who received injected beta-interferons or Copaxone between 1996 and 2011, and whom doctors followed for at least a year. Teva manufactures Copaxone, whose generic name is glatiramer acetate. The mean age of the patients in the study was 37.6 years, and 74.2 percent were women. Researchers defined a discontinuation of a DMT as a 90-day or longer gap in treatment. A third of the patients were treated with beta-interferon-1b, either Bayer HealthCare's Betaferon/Betaseron or Novartis' Extavia. It was the first such therapy available in Manitoba. Twenty-three percent of patients received beta-interferon-1a, either Biogen's Avonex or Merck's Rebif. And 21 percent received Copaxone. The median time before a patient discontinued a DMT was 4.2 years. Although 62.6 percent of patients discontinued treatment at some point, 57.4 percent either reinitiated it or switched to a different DMT. Patients who were on DMT at least a year were more likely to stay with it than those who stopped in the first year. Importantly, patients who started a DMT at a younger age were more likely to stop taking it than older patients. “Our results are also consistent with previous work examining persistence for other chronic medication classes, including statins, antihypertensives, bisphosphonates, and oral antidiabetic agents, where the risk for discontinuing drugs declined in a linear fashion with age,” the researchers wrote. The team also found that 16 percent of patients had to be hospitalized overnight, with 3 percent of the cases due to MS-related complications. And these hospitalized patients were more likely to stop their DMT treatment earlier, the researchers said. Summing up, the team said: "Subjects who were younger when starting a DMT, had prior MS-related hospitalizations, were more recently diagnosed with MS, or had a greater lag time between their MS diagnosis and DMT initiation were more likely to discontinue therapy." Although "not all of the factors identified with discontinuing DMT" can be modified, "they may help practitioners enhance MS care by identifying individuals who may be at particular risk for DMT discontinuation," the researchers concluded.

Merck’s cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the European Commission approve the tablets. “The positive opinion from the CHMP [the committee] is an extraordinary…

In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. **** Air Pollution May Trigger Relapses in MS Patients, French Study Finds Attention if you live in location where the air…

Air pollution, particularly tiny inhalable particles around 10 micrometers in diameter, is a likely trigger for relapses in multiple sclerosis patients, a French study reports. The study, “Air pollution by particulate matter PM10 may trigger multiple sclerosis relapses,” was published in the journal Environmental Research. A growing number of epidemiological studies suggest…

(Editor’s note: Tamara Sellman continues her occasional series on the MS alphabet with this first of two parts on terms starting with the letter “E.”) When it comes to multiple sclerosis, mastering an understanding of the disease means you need to mind your Ps and…

Read John Connor’s previous column, “Lemtrada I: This Island Couch.” Apologies for the pic of my edema–riddled right foot. If I put whiskers on it, my big toe could do a damn fine impersonation of a seal. On the bright side, a month ago it was twice this…

Mallinckrodt has enrolled its first relapsing multiple sclerosis (MS) patient into a Phase 4 clinical trial (NCT03126760) with H.P. Acthar Gel (Repository Corticotropin Injection) to see if the therapy can help treat relapse symptoms in patients who did not respond to high-dose steroids. If successful, the trial might resolve…

Relapse after First Lemtrada Course No Indication of Poor Long-Term Outcome, Study Finds Some MS patients being treated with Lemtrada report new exacerbation after they complete round one of the drug, and they wonder if this means the drug isn’t working.

Multiple sclerosis patients who benefited from Ocrevus (ocrelizumab) in two Phase 3 clinical trials continued to benefit when they extended their treatment, researchers reported. In fact, their annual relapse rates have fallen even further during the extension study than during the trials. The study, “Preliminary Results of the OPERA I and…

Long-term treatment for up to 12o weeks, with the investigational drug Ozanimod (RPC-1063), found to be effective and safe in patients with relapsing multiple sclerosis (MS) who participated in the RADIANCE clinical trial. Celgene, Ozanimod’s developer, presented the study, “Efficacy and Safety of Ozanimod in the Blinded Extension (120…

Cladribine tablets reduced relapsing multiple sclerosis patients’ annual relapse rate by 55 to 57 percent, depending on the dose, according to clinical trials. EMD Serono, a unit of Cladribine’s developer, Merck, presented the trial results at the 31st annual meeting of the Consortium of Multiple Sclerosis Centers in New Orleans,…

Multiple sclerosis (MS) patients who experienced a relapse between their first and second rounds of Lemtrada (alemtuzumab) had good treatment outcomes over the long run, according to a Phase 3 clinical trial. Those who relapsed after their first round ended up with annual relapse rates similar to those who didn’t…

A real-world medical-facilities setting has confirmed clinical trial findings that Gilenya (fingolimod) can reduce multiple sclerosis relapses, according to a Spanish study published in Plos One. Gilenya, developed by Novartis Pharmaceuticals, was the first oral disease-modifying therapy to obtain U.S. and European approval. The Food and Drug Administration and European Medicines Agency authorized…

Multiple sclerosis (MS) patients are largely moving away from injectable drugs and towards oral treatments when they switch from first to second-line MS therapies. But that might change with the introduction of Ocrevus (ocrelizumab), which has become the drug of choice for many neurologists advising patients on drug switches. The real-world analysis by…

The burden of moderate-to-severe relapses in multiple sclerosis (MS) patients is underappreciated, according to a study sponsored by the pharmaceutical company Mallinckrodt. Researchers discussed the findings at the American Academy of Neurology’s 69th annual meeting in Boston, April 22-28. The title of the presentation was “The Economic Burden Of…

Cladribine tablets reduce the risk of disability progression and relapse in patients with relapsing multiple sclerosis (MS), the CLARITY clinical trial indicates. The treatment was also well-tolerated and had a good safety profile, according to a presentation at the Annual Meeting of the American Academy of Neurology (AAN) in Boston,…

The inflammation in our bodies can be very sneaky. I am not talking about the good inflammation, also known as the group of hormones called eicosanoids (eye-KAH-sa-noids). This group of hormones provoke our immune system to fight diseases, viruses and other invaders and help in repairing tissues…

Lemtrada (alemtuzumab) may be more effective in preventing relapses in multiple sclerosis patients than the newly approved Ocrevus (ocrelizumab), according to a study presented April 28 at the American Academy of Neurology (AAN) 2017 Annual Meeting in Boston. The study, supported by Sanofi Genzyme and Bayer HealthCare Pharmaceuticals, compared…

Within the first two months of treatment, Ocrevus (ocrelizumab) reduced relapses in multiple sclerosis (MS) patients by more than half compared to those on Rebif, and almost completely prevented new brain lesions, according to data underscoring the drug’s rapid effects. Researchers from San Francisco-based Genentech and its Swiss parent…

Sanofi Genzyme will present new results on follow-up studies of its products Lemtrada (alemtuzumab) and Aubagio (teriflunomide), both of which have been approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The new data will be presented at the American Academy of Neurology (AAN) Annual Meeting taking…

Real-world data of treatment with Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) in relapsing multiple sclerosis (MS) patients suggest that treatment at early disease stages improves outcomes and prevents disability development. The studies, presented by Biogen at the American Academy of Neurology 2017 Annual Meeting in Boston, might challenge the…